Aerofit Post Market Investigation

NCT05925712 | Completed FDA Device

• 1 other identifier: CIP2022020161
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.

Conditions

Transfemoral Amputation; Amputation; Skin Health

Outcome Measures

Primary Outcomes (1)

• Subject perceived skin health (PEQ-RLH)

  PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH

  4 weeks

Secondary Outcomes (3)

• Subject perceived activity restriction and prosthesis use, TAPES-R

  4 weeks

• Subject perceived quality of life EQ-5D-5L

  4 weeks

• Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.

  4 weeks

Study Arms (2)

Crossover ABA

EXPERIMENTAL

Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times.

Device: AeroFit Seal-In Liner / Socket; Device: Seal-In Silicone Liner

Crossover BAB

EXPERIMENTAL

Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times.

Device: AeroFit Seal-In Liner / Socket; Device: Seal-In Silicone Liner

Interventions

AeroFit Seal-In Liner / Socket DEVICE

Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.

Crossover ABA; Crossover BAB

Seal-In Silicone Liner DEVICE

Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Crossover ABA; Crossover BAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kg\< body weight \< 136Kg
• Cognitive ability to understand all instructions and questionnaires in the study
• Intended for unilateral/bilateral individuals that fit the indications for use, fit within the specified criteria and with the limb length, shape and ability to use a prosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputation level: transfemoral
• Congenital transverse deficiency at femoral level
• Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFit Socket
• Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8 Minimum socket height per liner profile.
• Residual limb profile: Standard or conical
• Willing and able to participate in the study and follow the protocol
• Confident (all day) prosthetic users for more than 3 months
• Older than 18 years

You may not qualify if:

• Participating in another research study that may affect the participation or results of this study (in the opinion of the investigator)
• Users that have received Botox injection as treatment for residual limb sweat issue in the last 4 months

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (7)

Gainesville Prosthetics

Gainesville, Florida, 32606, United States

Location

NuTech Institute LLC

Indianapolis, Indiana, 46202, United States

Location

SRT Prosthetics & Orthotics NPC

Indianapolis, Indiana, 46202, United States

Location

Oakland Orthopedic

Bay City, Michigan, 48708, United States

Location

Perry Prosthetics

Perrysburg, Ohio, 43551, United States

Location

Baker Orthotics and Prosthetics

Arlington, Texas, 76015, United States

Location

Reach Orthotics and Prosthetics Services

Virginia Beach, Virginia, 23452, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 29, 2023
• Study Start: June 6, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)